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November 3, 2009

Rapid Weight Gain Associated With Antipsychotic Drugs

Young children and adolescents who take the newest generation of antipsychotic medications risk rapid weight gain and metabolic changes that could lead to diabetes, hypertension and other illnesses, according to the biggest study yet of first-time users of the drugs.

The study, to be published in The Journal of the American Medical Association, found that 257 young children and adolescents in New York City and on Long Island added 8 to 15 percent to their weight after taking the pills for less than 12 weeks.

The patients, ages 4 to 19, added an average of one to one-and-a-half pounds a week.

“The degree of weight gain is alarming,” said Dr. Wayne K. Goodman, head of a Food and Drug Administration advisory panel on the drugs last summer and chairman of psychiatry at Mount Sinai School of Medicine in Manhattan. “The magnitude is stunning,” he said.

Although the drugs’ influence on weight and metabolism had been previously detected, Dr. Goodman, said the speed and magnitude of the effects found in the study were greater than previously reported — findings he said were made possible by looking exclusively at new patients.

The four drugs in the study, the most popular antipsychotic medications, are industry blockbusters, with combined sales of $12.7 billion last year. And while all four caused weight gain, there were differences in the extent of the side effects. Among them, Zyprexa, made by Eli Lilly & Company, showed the most severe effects on weight and metabolism. The study’s authors, and an accompanying JAMA editorial, called for closer monitoring of patients taking the drugs, as well as additional long-term studies.

The drugs are prescribed for schizophrenia, bipolar disorder and a broad range of less serious psychological conditions. Their use by children and teenagers has been rising steadily. A 2008 study found that patients under 19 years old accounted for 15 percent of antipsychotic drug use in 2005, compared with 7 percent in 1996.

The drugs studied are in a class known as atypical antipsychotics, which are second-generation psychiatric drugs that in some cases regulate the receptors in the brain that interact with the mood-altering hormones serotonin and dopamine.

Abilify and Risperdal are the only two of the four drugs approved as pediatric treatments, for the severe mental conditions schizophrenia and bipolar disorder — and in Risperdal’s case, for some children with autism. More than 70 percent of atypical antipsychotics’ use in young children and teenagers has been off-label prescriptions for nonpsychotic conditions like attention deficit hyperactivity disorder, according to Stephen Crystal, a Rutgers University professor who studies the drugs.

Dr. Rapoport said Lilly’s Zyprexa drug, introduced in 1996, had been so heavily marketed that it was in widespread use before physicians began to recognize the severity of its side effects a few years ago. Zyprexa has continued selling in the range of nearly $3 billion a year in the United States even as concerns emerged about its tendency to cause patients to gain weight.

Abilify, from Bristol-Myers Squibb, showed the least metabolic effects among the four drugs in the study. “It’s considered a very good but weaker drug,” Dr. Rapoport said.

The other two drugs in the study, whose weight-related side effects fell between Zyprexa and Abilify, were Risperdal and Seroquel. Seroquel, from AstraZeneca, had United States sales of $2.2 billion in the first six months of this year, according to IMS Health, a research company. Abilify had sales of $1.9 billion during that period; Zyprexa, $1.5 billion; and Risperdal, from Johnson & Johnson, $660 million.

A Lilly spokesman, Jamaison R. Schuler, said the new research echoed Lilly’s own findings and previous studies about weight gain and metabolic changes that led to a label warning being placed on Zyprexa in October 2007.

The study covered 272 patients visiting clinics in Brooklyn, Queens and Long Island from 2001 to 2007. Fifteen patients who stopped taking their medicine were used as a control group. Their weight stayed level. The 257 patients who stayed on their drugs took detailed tests, including a fasting blood test to check for high glucose levels.

Their mean weight at the start of the study period was 118 pounds. But after about 11 weeks, those who took Zyprexa had gained 18.7 pounds; Seroquel, 13.4 pounds; Risperdal, 11.7 pounds; and Abilify, 9.7 pounds.

All but Abilify showed rapid and significant increases in one or more metabolic markers, which can presage adult obesity, hypertension and Type 2 diabetes. The metabolic markers included glucose, insulin, triglycerides and cholesterol.

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